Home Forums Industry FDA aims for accelerated approval to allow more drugs Reply To: FDA aims for accelerated approval to allow more drugs

Reply To: FDA aims for accelerated approval to allow more drugs

Home Forums Industry FDA aims for accelerated approval to allow more drugs Reply To: FDA aims for accelerated approval to allow more drugs

#1615
PhysioT12
Participant

Dear DD,

The FDA has decided to reduce the number of review cycles to help the applicants who can avoid common deficiencies that lead to review delay and application cycle. Moreover, FDA can enhance the competition into market. In one published document the FDA is validating and  reorganizing the review process, including new templates to make each cycle more efficient. According to them they will be taking additional steps to improve their own practices and to assist the industry to make sure their generic drug applications are acted upon as efficiently  possible. Hence, they will not be compromising the quality of the drug.